Patenting Biosimilars

In the world of pharmaceuticals, innovator companies seek to
develop products containing novel therapeutic agents such as compounds
and biologics. This requires an extensive R&D outlay, both for
pharmaceutical products, which will ultimately reach the market, and
those that fall at one of the many hurdles along the way. Such companies
hope to recoup some of these costs through patent revenue, and
obtaining patent protection for an innovative therapeutic agent is thus
central to the strategy for developing a product.

For a new therapeutic agent, perhaps the most valuable form of
patent protection available is a product claim broadly covering the
agent per se as well as related agents considered to possess
corresponding therapeutic activity. This will allow the innovator
company to prevent a third party from making, using, selling, or
importing the company’s pharmaceutical product. Depending on the scope
of the patent claims, such a patent may also allow the innovator company
to prevent a third party undertaking these activities in relation to
agents containing only arbitrary modifications. Other valuable forms of
patent protection include claims relating to methods of obtaining or
manufacturing the agent, formulations of the agent for administration,
and combination products including the agent and another pharmaceutical
product. In the US, obtaining claims relating to a method of treating a
certain condition using the agent is also possible. Such claims are not
permitted in Europe as they are considered to unduly restrict medical
professionals from treating patients using patented pharmaceuticals.
However, claims drafted as medical use claims, ie “compound X for use in
a method of treating disease Y”, are permitted and provide a similar
scope of protection.

Innovative therapeutic agents must be extensively tested before
they are given market approval. This can lead to a substantial delay in
bringing the product to market. To compensate for this perceived loss of
patent term, patentees can apply for a Supplementary Protection
Certificate (SPC) in Europe, although similar provisions are not
available in the US. An SPC is a national right that extends the
duration of a patent insofar as it relates to an approved pharmaceutical
product. The extension is granted for a maximum of five years, with an
additional six-month extension available if paediatric testing has been
conducted. SPCs can be extremely valuable as they are valid at the end
of a patent’s lifespan when the pharmaceutical product will be at its
most lucrative and generics companies will be keen to launch biosimilar
products. For this reason, an extension of patent term of only a few
days can be worth millions of pounds in revenue to the innovator
company.

Jennifer O’Farrell is a Partner in the biotechnology and life sciences group at Boult Wade Tennant. Jennifer has more than a decade’s experience of obtaining, attacking, and defending patents in the biotech field. She has extensive experience prosecuting patent applications before the EPO, as well as attacking and defending patents during opposition proceedings before the EPO, managing clients’ international patent portfolios, advising on filing strategies, and prosecuting patent applications before the UK Intellectual Property Office. Jennifer has been extensively involved in the filing of SPC applications throughout Europe.

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